A Multicenter, Open-Label, Dose Escalation Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of the DNA-PK Inhibitor M3814 in Combination With Avelumab With and Without Palliative Radiotherapy in Participants With Selected Advanced Solid Tumors
Phase of Trial: Phase I
Latest Information Update: 29 Nov 2019
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At a glance
- Drugs Avelumab (Primary) ; Nedisertib (Primary)
- Indications Solid tumours
- Focus Adverse reactions; First in man; Pharmacokinetics
- Sponsors EMD Serono
- 25 Nov 2019 Protocol of this trial has been amended to increase treatment arms from 2 to 3, primary endpoints are added for pharmacokinetics, Planned patient numbers are increased from 24 to 54 and indication lung cancer is removed.
- 25 Nov 2019 Planned number of patients changed from 24 to 54.
- 17 Sep 2019 Planned End Date changed from 14 Jan 2020 to 13 Apr 2020.